81 FR 54817 - Prospective Grant of Exclusive Patent License: Development of T Cell Receptors (TCRs) Targeting the KRAS G12D Mutation for the Treatment of Cancer

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 159 (August 17, 2016)

Page Range		54817-54817
FR Document		2016-19549

This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Cancer Institute, National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to Kite Pharma, Inc. (``Kite'') located in Santa Monica, CA to practice the inventions embodied in the following patent applications:

Federal Register, Volume 81 Issue 159 (Wednesday, August 17, 2016)

[Federal Register Volume 81, Number 159 (Wednesday, August 17, 2016)]
[Notices]
[Page 54817]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-19549]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent License: Development of T 
Cell Receptors (TCRs) Targeting the KRAS G12D Mutation for the 
Treatment of Cancer

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 
part 404, that the National Cancer Institute, National Institutes of 
Health, Department of Health and Human Services, is contemplating the 
grant of an exclusive patent license to Kite Pharma, Inc. (``Kite'') 
located in Santa Monica, CA to practice the inventions embodied in the 
following patent applications:

Intellectual Property

    United States Provisional Patent Application No. 62/084,654, filed 
November 26, 2014, entitled ``Anti-mutated KRAS T Cell Receptors'' [HHS 
Reference No. E-028-2015/0-US-01]; and
    PCT Application No. PCT/US2015/062269 filed November 24, 2015 
entitled ``Anti-mutated KRAS T Cell Receptors'' [HHS Reference No. E-
028-2015/1-PCT-01].
    The patent rights in these inventions have been assigned to the 
government of the United States of America. The prospective exclusive 
license territory may be worldwide and the field of use may be limited 
to the development, manufacture and commercialization of retrovirally-
engineered mutated KRAS TCR-based autologous peripheral blood T cell 
therapy products as set forth in the Licensed Patent Rights for the 
treatment of human cancers.

DATES: Only written comments and/or applications for a license which 
are received by the National Cancer Institute on or before September 1, 
2016 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated exclusive license should be 
directed to: Andrew Burke, Ph.D., Licensing and Patenting Manager, 
Technology Transfer Center, National Cancer Institute, 9609 Medical 
Center Drive, MSC 9702, Rockville, MD 20852; Telephone: (240) 276-5484; 
Email [email protected].

SUPPLEMENTARY INFORMATION: The present invention describes an isolated 
T cell receptor (TCR) which recognizes the G12D mutation of the Kristen 
rat sarcoma viral oncogene homolog (KRAS) protein within the context of 
major histocompatibility complex HLA-A11 presentation.
    KRAS is an oncogene with a well-characterized role in the formation 
of several human cancers, including: Pancreatic, colorectal and lung. 
Certain mutations, such as the substitution of aspartic acid or valine 
for glycine at codon 12 (termed G12D and G12V, respectively), occur at 
relatively high frequency and may represent amenable targets for 
immunotherapies. Due to the restricted expression of KRAS G12D in pre-
cancerous and malignant cells, engineered T cell therapies based on the 
present invention may be useful for the treatment of select cancers.
    The prospective exclusive license will be royalty bearing and will 
comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part 
404. The prospective exclusive license may be granted unless within 
fifteen (15) days from the date of this published notice, the NCI 
receives written evidence and argument that establishes that the grant 
of the license would not be consistent with the requirements of 35 
U.S.C. 209 and 37 CFR part 404.
    Complete applications for a license in an appropriate field of use 
that are timely filed in response to this notice will be treated as 
objections to the grant of the contemplated exclusive license. Comments 
and objections submitted to this notice will not be made available for 
public inspection and, to the extent permitted by law, will not be 
released under the Freedom of Information Act, 5 U.S.C. 552.

    Dated: August 8, 2016.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2016-19549 Filed 8-16-16; 8:45 am]
 BILLING CODE 4140-01-P

Federal Register / Vol. 81, No. 159 / Wednesday, August 17, 2016 / Notices 54817

additional information for the meeting an exclusive patent license to Kite The prospective exclusive license will
will be posted when available. Pharma, Inc. (‘‘Kite’’) located in Santa be royalty bearing and will comply with
(Catalogue of Federal Domestic Assistance Monica, CA to practice the inventions the terms and conditions of 35 U.S.C.
Program Nos. 93.233, National Center for embodied in the following patent 209 and 37 CFR part 404. The
Sleep Disorders Research; 93.837, Heart and applications: prospective exclusive license may be
Vascular Diseases Research; 93.838, Lung granted unless within fifteen (15) days
Diseases Research; 93.839, Blood Diseases Intellectual Property
from the date of this published notice,
and Resources Research, National Institutes United States Provisional Patent the NCI receives written evidence and
of Health, HHS) Application No. 62/084,654, filed argument that establishes that the grant
Dated: August 11, 2016. November 26, 2014, entitled ‘‘Anti- of the license would not be consistent
Michelle Trout, mutated KRAS T Cell Receptors’’ [HHS with the requirements of 35 U.S.C. 209
Program Analyst, Office of Federal Advisory Reference No. E–028–2015/0–US–01]; and 37 CFR part 404.
Committee Policy. and Complete applications for a license in
[FR Doc. 2016–19545 Filed 8–16–16; 8:45 am] PCT Application No. PCT/US2015/ an appropriate field of use that are
BILLING CODE 4140–01–P
062269 filed November 24, 2015 timely filed in response to this notice
entitled ‘‘Anti-mutated KRAS T Cell will be treated as objections to the grant
Receptors’’ [HHS Reference No. E–028– of the contemplated exclusive license.
DEPARTMENT OF HEALTH AND 2015/1–PCT–01]. Comments and objections submitted to
HUMAN SERVICES The patent rights in these inventions this notice will not be made available
have been assigned to the government of for public inspection and, to the extent
National Institutes of Health the United States of America. The permitted by law, will not be released
prospective exclusive license territory under the Freedom of Information Act,
National Cancer Institute; Amended may be worldwide and the field of use
Notice of Meeting 5 U.S.C. 552.
may be limited to the development,
manufacture and commercialization of Dated: August 8, 2016.
Notice is hereby given of a change in
retrovirally-engineered mutated KRAS Richard U. Rodriguez,
the meeting of the National Cancer
Advisory Board, September 07, 2016, TCR-based autologous peripheral blood Associate Director, Technology Transfer
T cell therapy products as set forth in Center, National Cancer Institute.
09:00 a.m. to September 07, 2016, 5:00
p.m., National Institutes of Health, the Licensed Patent Rights for the [FR Doc. 2016–19549 Filed 8–16–16; 8:45 am]
Building 31, 31 Center Drive, treatment of human cancers. BILLING CODE 4140–01–P

Conference Room 10, Bethesda, MD DATES: Only written comments and/or
20892 which was published in the applications for a license which are
Federal Register on August 08, 2016, 81 received by the National Cancer DEPARTMENT OF HEALTH AND
FR 52452. Institute on or before September 1, 2016 HUMAN SERVICES
This meeting notice has been will be considered.
National Institutes of Health
amended to change the end time of the ADDRESSES: Requests for copies of the
open session to 2:45 p.m. The closed patent application, inquiries, and National Institute on Aging; Notice of
session has also been amended to begin comments relating to the contemplated Closed Meeting
at 3:00 p.m. and end at 4:15 p.m. The exclusive license should be directed to:
meeting is partially closed to the public. Andrew Burke, Ph.D., Licensing and Pursuant to section 10(d) of the
Dated: August 11, 2016. Patenting Manager, Technology Transfer Federal Advisory Committee Act, as
Melanie J. Gray, Center, National Cancer Institute, 9609 amended (5 U.S.C. App.), notice is
Medical Center Drive, MSC 9702, hereby given of the following meeting.
Program Analyst, Office of Federal Advisory
Committee Policy. Rockville, MD 20852; Telephone: (240) The meeting will be closed to the
[FR Doc. 2016–19544 Filed 8–16–16; 8:45 am]
276–5484; Email andy.burke@nih.gov. public in accordance with the
BILLING CODE 4140–01–P SUPPLEMENTARY INFORMATION: The provisions set forth in sections
present invention describes an isolated 552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
T cell receptor (TCR) which recognizes as amended. The grant applications and
DEPARTMENT OF HEALTH AND the G12D mutation of the Kristen rat the discussions could disclose
HUMAN SERVICES sarcoma viral oncogene homolog confidential trade secrets or commercial
(KRAS) protein within the context of property such as patentable material,
National Institutes of Health major histocompatibility complex HLA– and personal information concerning
A11 presentation. individuals associated with the grant
Prospective Grant of Exclusive Patent KRAS is an oncogene with a well- applications, the disclosure of which
License: Development of T Cell characterized role in the formation of would constitute a clearly unwarranted
Receptors (TCRs) Targeting the KRAS several human cancers, including: invasion of personal privacy.
G12D Mutation for the Treatment of Pancreatic, colorectal and lung. Certain Name of Committee: National Institute on
Cancer mutations, such as the substitution of Aging Initial Review Group; Neuroscience of
AGENCY: National Institutes of Health, aspartic acid or valine for glycine at Aging Review Committee.
HHS. codon 12 (termed G12D and G12V, Date: September 29–30, 2016.
respectively), occur at relatively high Time: 4:00 p.m. to 12:00 p.m.
mstockstill on DSK3G9T082PROD with NOTICES

ACTION: Notice. Agenda: To review and evaluate grant
frequency and may represent amenable
targets for immunotherapies. Due to the applications.
SUMMARY: This is notice, in accordance
Place: DoubleTree by Hilton Bethesda,
with 35 U.S.C. 209 and 37 CFR part 404, restricted expression of KRAS G12D in 8120 Wisconsin Ave., Bethesda, MD 20814.
that the National Cancer Institute, pre-cancerous and malignant cells, Contact Person: Jeannette L. Johnson,
National Institutes of Health, engineered T cell therapies based on the Ph.D., Deputy Review Branch Chief, National
Department of Health and Human present invention may be useful for the Institutes of Health, National Institute on
Services, is contemplating the grant of treatment of select cancers. Aging, Gateway Building, Bethesda, MD

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Document Created: 2018-02-09 11:35:04
Document Modified: 2018-02-09 11:35:04

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Only written comments and/or applications for a license which are received by the National Cancer Institute on or before September 1, 2016 will be considered.
FR Citation		81 FR 54817

81 FR 54817 - Prospective Grant of Exclusive Patent License: Development of T Cell Receptors (TCRs) Targeting the KRAS G12D Mutation for the Treatment of Cancer

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 81, Issue 159 (August 17, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health